BEUDAMED
    FDA Recall Terminated

    AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    Recall: Z-1578-2018 · Initiated April 27, 2017

    Recall

    Recall Number
    Z-1578-2018
    Event Number
    78412
    Firm
    Vyaire Medical
    FEI Number
    2050001
    Product Code
    OEV
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 27, 2017
    Posted
    May 10, 2018
    Terminated
    May 9, 2019
    Address
    75 N Fairway Dr, Vernon Hills, IL, 60061-1845

    Description

    AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    Reason

    The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.

    Action

    The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:[email protected].; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129. For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: [email protected].

    Distribution

    Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

    Quantity

    20 units